The invention relates to a mobile system for separating donor blood by means of gravitational force into erythrocyte concentrate and plasma, having a first bag serving as a reservoir for the blood to be separated and at least a second and third bag for respectively receiving erythrocyte concentrate and plasma, and also multiple tubes for connecting the flexible bags consisting of plastic material to a separator module having a separating membrane in the form of a bundle of hollow fibers.
The separation of blood is carried out using centrifugation in the method used as a rule for separating donor blood into erythrocyte concentrate and plasma. A four-bag system is commonly used thereby, wherein the bags are sterilely connected via tubing. The first bag, filled with whole blood in the course of a donation, is connected via a leukocyte filter to the second bag for receiving filtered whole blood. When this second bag is filled with filtered blood, it is deaerated and heat-sealed.
The centrifugation is carried out in a rotator, wherein rotational speed, centrifugation time, and temperature are determined by the blood components to be separated and the bag system used. The centrifuged whole blood is introduced into a separator, which detects the separation layer between plasma and cells using optical detectors, for example, and then presses them out into the respective connected bags.
Although this is a proven standard method for preparing blood components, it also has several disadvantages.
Since electrical power is inevitably required to perform the centrifugation and separation, this standard method for preparing blood components can only be carried out in the presence of a corresponding power source.
In addition to the high acquisition and maintenance costs which are connected with this known system, it is disadvantageous that the functional implementation of the blood separation can only be carried out by trained personnel. Furthermore, due to the high rotational speed, red blood cells can burst upon impact with the walls of the centrifuge, and their contents can be discharged to the surrounding plasma. As these red blood cells can also contain poisonous substances and pathogens, in addition to hemoglobin and cell fragments, these dangerous contents must be extracted prior to further processing of the plasma, which causes additional work and costs.
It is also disadvantageous that preparation of stored blood, carried out in correspondingly equipped, central facilities, is often associated with a time delay if the blood donation is carried out in mobile donation stations and the donations must be transported over long distances to the corresponding center before the fractionation into blood components can be carried out there.
A mobile system for separating donor blood by means of gravitational force into erythrocyte concentrate and plasma of the type described at the beginning is known under the designation “ErySep Classic” from Lmb Technologie GmbH. This known system, independent of an external power source, has the fundamental advantage that it enables the separation of donor blood without the necessity of conventional logistics because it requires no electricity or electrical devices such as centrifuges, plasma extractors, and the like.
In the case of this known system, the different necessary bags are connected to the separator module via tubes, which are permanently joined to the connectors of the separator module, in particular glued or heat-sealed, so that this complete system must be sterilized as a unit. If the mandatory test of the donor blood from the pre-donation bag indicates that the donor blood is unusable, the complete system consisting of bags, connecting tubes, and separator module becomes unusable and, accordingly, the complete unit, intended for single use, must be disposed of.